GUAIFENESIN- guaifenesin liquid 
Oncor Pharmaceuticals

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Guaifenesin Oral Solution USP

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

Warnings

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Drug Facts(continued)

Other information

Inactive ingredients

Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Manufactured for:
Oncor Pharmaceuticals
8815 Center Park Dr. Suite 430
Columbia, Maryland 21045


Rev. 05/24

PRINCIPAL DISPLAY PANEL

NDC 83720-503-16

ONCOR PHARMACEUTICALS

Guaifenesin

Oral Solution USP

100 mg/5 mL

Expectorant

Relieves Chest Congestion

Sugar Free • Alcohol Free

Cherry Flavor

16 fl. oz. - 473 mL

Label

GUAIFENESIN 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-503
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM (UNII: 9NEZ333N27)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83720-503-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/10/2024
Labeler - Oncor Pharmaceuticals (119032580)
Registrant - Oncor Pharmaceuticals (119032580)

Revised: 5/2024
Document Id: 181cf7c9-36ac-415c-e063-6294a90abe06
Set id: fd35036c-b722-48a3-85fd-60471beb6e74
Version: 3
Effective Time: 20240510
 
Oncor Pharmaceuticals